Food and Drug Administration Approves Unithroid

First New Drug Application for Thyroid Drug Levothyroxine Sodium

August 22, 2000 --- On August 22, 2000, the Food and Drug Administration (FDA) approved the first New Drug Application (NDA) for Unithroid, a brand of thyroid hormone replacement drug known as levothyroxine sodium for treatment of hypothyroidism in adults and children. It is expected that approvals for other brands of levothyroxine will be announced in coming months.

According to the FDA's report on this approval, "Although oral levothyroxine drugs products have been marketed in the United States since the 1950's, the approval of Unithroid represents the first time that a single ingredient oral levothryoxine product has been approved by the FDA. The unapproved thyroid hormone replacement products that have been on the market have been associated with stability and potency problems. These problems have resulted in product recalls and have the potential to cause serious health consequences to the public. With the approval of the NDA for Unithroid, patients and physicians now have available to them an oral levothryroxine sodium drug product that has been determined to be safe and effective by the FDA and that also meets FDA standards for manufacturing processes, purity, potency, and stability."

The drug that was approved, Unithroid, is not one that has been marketed. The levothyroxine market has typically been dominated by Synthroid, the levothyroxine manufactured by Knoll Pharmaceuticals, which was the subject of a recent class action lawsuit settlement.

In the August 14, 1997 Federal Register, the FDA stated:

no currently marketed orally administered levothyroxine sodium product has been shown to demonstrate consistent potency and stability and, thus, no currently marketed orally administered levothyroxine sodium product is generally recognized as safe and effective.

The unapproved thyroid hormone replacement products that had been on the market had been associated with stability and potency problems. These problems resulted in product recalls and had the potential to cause serious health consequences to the public.

NOTE: For a complete history of the FDA's actions, and the FDA's call for a New Drug Application for levothyroxine products, read: Synthroid and other Levothyroxine Drugs Have Significant Stability and Potency Problems: FDA Takes Action to Require Manufacturers to Demonstrate Safety, Efficacy and Consistency, Mary Shomon's comprehensive 1997 article.

To address these concerns, the agency announced that after August 14, 2001, any orally administered levothyroxine drug product must be the subject of an approved New Drug Application. If there is no such approved application, the product will be subject to regulatory action as an unapproved new drug.

Unithroid is manufactured and distributed by Jerome Stevens Pharmaceuticals of Bohemia, NY.

Jerome Stevens Pharmaceuticals
60 Davinci Drive
Bohemia, NY 11716-2613
Phone: 631-567-1113

What are the Implications for Patients?

According to the FDA, "With the approval today of Unithroid, patients and physicians will now have available to them an oral levothryroxine sodium drug product that has been determined to be safe and effective by the FDA and that also meets FDA standards for manufacturing processes, purity, potency, and stability."

The materials filed as part of the NDA approval also offer some interesting information for thyroid patients taking levothyroxine. For example, the NDA submittal information included detailed information on Hypersensitivity Reactions of levothyroxine - basically, side effects that some people experience while on levothyroxine.